1. Field of the Invention
The present invention is generally directed to management of breast cancer. More particularly, the present invention relates to a breast implant that optimizes breast reconstruction and local regional treatment after surgical intervention for breast cancer.
2. Discussion of the Background
Studies have demonstrated that a good aesthetic result after breast cancer surgery has a key role in the overall outcome of patients. The psychological consequences of absence or deformity of the breast after surgery can be devastating. In the quest for better patient outcome, breast surgery has evolved to a point in which most of the patients these days do not need complete resection of the breast for the management of their cancer. Partial breast resection is accepted and promoted by medical experts even when radiotherapy is required because it is much better tolerated than total mastectomy. But there are still a lot of patients in which mastectomy, complete resection of the breast, is required as the indicated surgical intervention. Again, the psychological effects for these kinds of surgery are devastating and debilitating.
Reconstructive surgery has been developed to treat deformity and acquired absence of the breast. But the real availability and accessibility of breast reconstructions are limited mostly because of the complexity of breast reconstructive surgery when myocutaneous and free tissue flaps are used. Breast reconstruction with implantable prostheses are more simple and accessible, but less aesthetically favorable. Therefore, a breast implant should be developed to meet requirements in a way that breast implant reconstruction could achieve the same aesthetic results than reconstruction with tissue flaps.
Currently the problem with breast implant reconstruction after mastectomy is that the implants become very noticeable underneath breast skin flaps. First, the implant itself has a very unnatural feeling. Also, the process of encapsulation adds to the situation causing the entire natural drop-like appearance of the breast tissue to be lost and increasing breast stiffness.
Furthermore, if additional local treatment, such as radiotherapy, is needed after surgery, the implant may interfere with its planning and administration. Finally, when implants are used for breast reconstruction in most cases several surgical interventions are required until the desirable volume and shape are achieved.
Presently, the available prostheses devices emerge from the family of implants developed initially for aesthetic purposes. This is a founding problem because the requirements of breast implants to meet the needs after aesthetic breast surgery are very different than those for reconstructive surgery after mastectomy. Some implants, more particularly the ones used for aesthetic breast surgery, have been improved to make them less noticeable after breast reconstruction. However, the main focus in their improvements is the implant filling and not the implant shell or outer surface. The shell serves as a support for the implant filling, however the material used for the implant filling is just one of the factors affecting how the implant feels.
The elasticity of the shell is a characteristic that affects the feeling and look of the breast. For example, if the elasticity of the shell of the implant is less than the elasticity of the skin then you will always feel the implant below the skin flaps.
Another important remark is the body reaction, such as encapsulation to the implant, which makes the implant more noticeable and uncomfortable to the patient. As mentioned before, the shell is the implant's portion closer to the patient's tissue, therefore the coating of the shell affects the mastectomy bed as well the feeling of the implant. Encapsulation is more accentuated after reconstruction, because skin flaps are thinner. The body reaction that leads to implant encapsulation is the same reaction that leads to tissue adhesions surrounding non-biodegradable material which is a foreign body reaction. Whenever the body is incapable of degrading or attacking any given “foreigner”, such as prolene and silicone, it will elicit a foreign body reaction where it tries to encapsulate the invader. This reaction creates a very high collagen content pseudomembrane with myofibroblasts that contracts around it. Therefore, there is a need to reduce the encapsulation reaction in order to provide a more natural feeling of the breast implant.
Further, as mentioned before, in order to provide a breast implant that does not just focuses on the aesthetics but also the reconstructive breast cancer surgery certain features can be added to make them more useful for breast reconstruction and local regional therapy. For example, the delivery of a drug for local treatment to the mastectomy bed in order to reduce, control and treat the patient's condition. Therefore, there is a need of a breast implant capable of delivering a drug or serving for post-mastectomy local treatment after breast reconstructive surgery.
While some breast implants, such as previous breast implant directed to reconstruction surgery, have proven to assist with post-mastectomy regional treatment and reconstruction, still further improvements would be desirable. In general, it would be desirable to provide a breast implant improving the shell performance with regards to reactions with the patient's tissue surrounding the implant, while maintaining a natural look and sensation of the implant. The ideal implant would be one that you can use for breast reconstruction immediately after mastectomy, allows for local regional treatment after surgery, does not encapsulate and feels like a normal breast. In addition, it would permit inflation or deflation at any time after surgery. After insertion during mastectomy no further operating room intervention would be needed. The purpose of this invention is to fulfill those requirements.
Any shortcoming mentioned above is not intended to be exhaustive, but rather is among many that tends to impair the effectiveness of previously known techniques for breast reconstruction; however, shortcomings mentioned here are sufficient to demonstrate that the methodologies appearing in the art have not been satisfactory and that a significant need exists for the techniques described and claimed in this disclosure.